Cleanroom PFXT Series - Latex Gloves (Class 100 ISO 5)

CT International PFXT Series gloves are powder-free, non-sterile natural rubber latex gloves designed for ISO 5 / Class 100 compatible controlled environments. Their performance profile combines latex elasticity, a textured external surface, a tapered beaded cuff, double chlorination, double-bagged packaging, and 10-inch or 12-inch length options.

In critical manufacturing, a glove is not simply a barrier between the operator and the task. It is a process-contact surface. The glove can touch tools, components, packaging, wipers, containers, controls, and product-contact equipment. For that reason, material identity, surface treatment, packaging, fit, cuff overlap, and change discipline must be managed as part of the contamination-control system.

Manufacturer literature describes PFXT Series gloves as Class 100 / ISO 5 compatible and suitable for cleaner controlled environments. That claim supports their use as a cleanroom glove platform, but it should not be restated as an independent ISO certification. ISO cleanroom classification applies to the environment; the glove is selected and qualified as a consumable used within that environment.

The reviewed current public product sheet does not provide a numerical particle-count limit, ionic-extractable limit, nonvolatile-residue limit, or lot-release acceptance range. Legacy CT International literature reports particle and extractable testing under IES-RP-CC-005.2, but it does not publish the resulting numerical values.

PFXT gloves are non-sterile. Their double-bagged packaging supports controlled material transfer, but double bagging is not a sterile-barrier claim. A glove can be suitable for an ISO-classified manufacturing environment without being appropriate for an aseptic task that requires sterile hand protection.

The facility should define which activities permit a non-sterile glove and which require a sterile glove. That distinction is especially important in sterile compounding, aseptic manipulation, sterile filling, or any operation where glove sterility is an explicit procedural requirement.

PFXT manufacturer literature publishes total protein content of less than 50 µg/g of glove using the Modified Lowry Method. The gloves are powder-free and double chlorinated, which reduces powder exposure and is intended to reduce protein and contact-sensitizer background.

Those characteristics do not make the glove allergen-free, hypoallergenic, or appropriate for a person with known natural rubber latex sensitivity. Protein testing measures a defined characteristic of the glove; it does not demonstrate the complete absence of every latex allergen or every chemical that may cause irritation or sensitization.

Chlorination is used to modify the latex surface and support powder-free glove processing. For PFXT, the manufacturer associates double chlorination with reduced protein and contact-sensitizer background. This can improve the cleanliness and handling profile compared with an untreated or powdered latex glove.

Double chlorination does not establish sterility, chemical resistance, accelerator-free formulation, or zero-allergen status. The reviewed literature does not identify PFXT as accelerator-free, and that claim should not be added without supporting manufacturer documentation.

The PFXT100 Series provides a nominal 10-inch glove length. The PFXT200 Series provides a nominal 12-inch length for additional wrist and lower-forearm coverage. Both versions use the same published 6.5 mil nominal thickness.

A 12-inch glove may provide more reliable overlap with a cleanroom sleeve, but the actual interface depends on glove size, sleeve construction, operator movement, gowning sequence, and any cuff-sealing method. Qualification should include movement testing rather than relying only on nominal length.

PFXT gloves are supplied in a double-bagged configuration. This allows a facility to remove or decontaminate the outer package at a controlled transition point while retaining an inner package for cleaner introduction and dispensing.

Transfer effectiveness depends on the site procedure. Bringing a shipping-exposed outer bag directly into an ISO 5 work area defeats much of the value of double packaging. Conversely, treating the inner bag as sterile would overstate the product qualification.

The reviewed public PFXT materials do not provide a chemical-permeation or degradation chart. ISO 5 compatibility, natural latex construction, and 6.5 mil thickness therefore should not be converted into a broad chemical-protection claim.

Facilities should evaluate the glove against each solvent, disinfectant, process chemical, and expected contact duration. Glove swelling, softening, tackiness, discoloration, loss of elasticity, or surface damage are reasons for immediate replacement and process review.

Oil-based hand creams and lotions may damage natural rubber latex. Use only facility-approved, cleanroom-compatible hand-care products that have been evaluated for glove and process compatibility.

Published PFXT sources do not consistently identify the same ASTM D3578 revision. The current Benchmark product page cites ASTM D3578-95, another current downloadable sheet cites ASTM D3578-05, and a legacy CT International sheet cites ASTM D3578-00.

For general product content, the defensible wording is that PFXT is listed as meeting ASTM D3578. For a validated specification, supplier agreement, or audit package, obtain the current controlled document and identify the exact revision applicable to the supplied lot.

Manufacturer literature also states that sampling is performed in accordance with MIL-STD-105E. That statement does not replace a lot-specific certificate or the facility’s incoming-inspection plan.

Select the correct glove size before entering the controlled area. An undersized glove can place unnecessary stress on the film and cuff; an oversized glove can reduce tactile control and create excess material at the fingertips.

Hands should be clean and completely dry before donning. Open and dispense the gloves according to the approved material-transfer and gowning sequence. Avoid touching uncontrolled surfaces with the glove exterior and avoid snapping or excessively stretching the cuff.

Replace gloves immediately after tearing, puncture, visible contamination, uncontrolled contact, chemical exposure, wetting, tackiness, loss of elasticity, or any event defined by the site SOP. Establish task- or batch-based change points rather than continuing use until visible failure.

• Equating ISO 5 compatibility with sterility: PFXT is non-sterile. Prevention: select a sterile glove whenever the procedure or SOP requires sterile hand protection.
• Treating low-protein latex as allergen-free: Less than 50 µg/g does not eliminate latex allergy risk. Prevention: maintain a qualified synthetic alternative and follow the facility latex policy.
• Publishing an unsupported AQL: The reviewed current literature does not state one. Prevention: request current controlled documentation before adding an AQL to the specification.
• Inventing numerical particle or extractable limits: ISO 5 compatibility is not a numerical glove-cleanliness result. Prevention: obtain current test reports for quantitative requirements.
• Assuming cleanroom classification establishes chemical protection: No current public permeation chart was identified. Prevention: qualify each chemical and exposure duration.
• Introducing the outer bag into the critical area: Shipping-exposed packaging becomes a contamination vector. Prevention: define package removal and wipe-down points in the material-transfer SOP.
• Insufficient gown-cuff overlap: A 10-inch glove may not provide adequate coverage for every gown system. Prevention: assess the glove and garment together under movement.
• Using oil-based lotion with latex: Incompatible hand-care products can weaken the glove. Prevention: approve cleanroom-compatible hand-care products through EHS and Quality.
• Hard-coding the wrong ASTM revision: Published source versions conflict. Prevention: use revision-neutral public wording and current lot documentation in the controlled specification.
• Unauthorized substitution: A generic powder-free latex glove may have different cleanroom packaging, protein content, cuff length, surface treatment, or cleanliness controls. Prevention: lock the approved PFXT code into procurement and change control.

Receiving personnel should verify the product family, length, size, catalog number, lot identification, case quantity, and packaging integrity. The legacy CTI/SOS codes and current Benchmark listing codes are:

Each case contains 1,000 gloves, configured as 100 gloves per pack and 10 packs per case. Maintain lot traceability after inner packs are removed from the shipping case.

The correct companion or alternative should address the reason the PFXT platform was selected: cleanroom compatibility, glove material, sterility, cuff coverage, or process-contact control.

• Latex-free ISO 5 alternative: Ansell Nitrilite™ 93-311 Cleanroom Nitrile Gloves — consider where the process requires an ISO 5 compatible synthetic glove or a natural-rubber-latex alternative.
• Sterile latex alternative: Ansell AccuTech™ 91-225 Sterile Latex Cleanroom Gloves — consider where the procedure requires sterile latex gloves rather than a non-sterile PFXT configuration.
• Cleanroom wiper: Texwipe TX1009 AlphaWipe™ 9 in x 9 in Polyester Cleanroom Wiper — supports controlled surface cleaning without relying on the glove as the primary pickup medium.

Use current manufacturer and lot-specific documentation as the controlled source for cleanroom qualification, incoming inspection, allergen-risk review, and regulatory claims.

• Benchmark Products PFXT Series Product Page and Certificate Request
• PFXT Series Product Data Sheet
• FDA Natural Rubber Labeling Guidance
• NIOSH Latex Allergy Prevention Guide

This Technical Vault content is provided for general operational guidance, product comparison, and procurement planning only. It does not replace manufacturer documentation, lot-specific certificates, facility SOPs, contamination-control assessments, chemical-permeation testing, occupational-health requirements, gowning qualification, or applicable regulatory standards. This product contains natural rubber latex and is non-sterile. Verify suitability for the exact process and user population before use.